510(k) Report

510(k) · Cleared

Cleared

Biojector 2000 Model 1B02000

K960373510(k) TraditionalCleared Mar 5, 1997404-day reviewClass II21 CFR 880.5430

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bioject, Inc. · KZE Injector, Fluid, Non-Electrically Powered

Cleared on Mar 5, 1997 as substantially equivalent to K920631 (Bioject, Inc., 1994) after a 404-day review. Its family tree reaches back 1 generation to 1994. 9 later devices descend from it.

Decided
Mar 5, 1997
Review
404 days
Class
Class II
Product code
KZE
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K920631 (1994). 9 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2009: 4 descendants cleared2012: 1 descendant cleared2003: 1 descendant cleared2011: 2 descendants clearedK920631 · Bioject Jet Injection System · Bioject, Inc. · 19941990200020102020
Descendants, by generation 1 generation forward: 7 descendants2 generations forward: 2 descendants K920631 · Bioject Jet Injection System · Bioject, Inc. · 19940
  1. Root · 1 generation backK920631 Bioject Jet Injection SystemBioject, Inc. · 1994
  2. This deviceK960373 Biojector 2000 Model 1B02000Bioject, Inc. · 1997
  3. Descendant · cites it directly · 3 of its ownK081532 Pharmajet Needle-Free Injection SystemPharmajet, Inc. · 2009
  4. Descendant · 2 generations on · 1 of its ownK110456 Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemPharmajet, Inc. · 2011
  5. Descendant · cites it directly · 0 of its ownK121270 Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc. · 2012
  6. Descendant · 2 generations on · 0 of its ownK111517 Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01…Pharmajet, Inc. · 2011
  7. Descendant · cites it directly · 0 of its ownK090959 Lectrajet Needle-Free Injection System, Model: M3 RAD'Antonio Consultants International, Inc. (Dci) · 2009

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12009: 42011: 22012: 1
2003high 4 (2009) · low 0 (2005)2026

Most influential descendants

Showing 5 of 9 · See all
  • K081532Pharmajet Needle-Free Injection SystemPharmajet, Inc. · 2009 · cites it directly3descendants
  • K110456Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemPharmajet, Inc. · 2011 · 2 generations on1descendant
  • K121270Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc. · 2012 · cites it directly0descendants
  • K111517Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis Injector…Pharmajet, Inc. · 2011 · 2 generations on0descendants
  • K090959Lectrajet Needle-Free Injection System, Model: M3 RAD'Antonio Consultants International, Inc. (Dci) · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K920631Bioject Jet Injection SystemBioject, Inc.1994—
0 (this device)K960373Biojector 2000 Model 1B02000Bioject, Inc.1997—
+1K081532Pharmajet Needle-Free Injection SystemPharmajet, Inc.2009—
+2K110456Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemPharmajet, Inc.2011—
+1K121270Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc.2012—
+2K111517Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis…Pharmajet, Inc.2011—
+1K090959Lectrajet Needle-Free Injection System, Model: M3 RAD'Antonio Consultants International, Inc. (Dci)2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200940
201120
201210
FIG. 1 — Lineage of K960373, 1994–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K920631Bioject Jet Injection System
Summary page 4
…less Injector, Jet Injector Classification Name: Non-electrically Powered Fluid Injector, 21 CFR 880.5430 (a)(3) Predicate Device: Biojector® 2000 Jet Injection System (K920631) (a)(4) Device Description: The Biojector® 2000 is a needle free injection management system designed to deliver drugs both subc…
Bioject, Inc.1994—

Also cleared against K920631: 3 other devices →

What descends from it? (9)

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K081532Pharmajet Needle-Free Injection SystemPharmajet, Inc.20093
K121270Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc.20120
K090959Lectrajet Needle-Free Injection System, Model: M3 RAD'Antonio Consultants International, Inc. (Dci)20090
K090003ZetajetBioject, Inc.20090
K082138Airgent, Model AG7000010Perfaction, Inc.20090
K032976Biovalve Miniject Needle-Free Injection System, Model FG-01-001Biovalve Technologies, Inc.20040
K024018Avant Guardian 101Avant Medical Corporation20030

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K081532 (Pharmajet, Inc., 2009) has gone furthest, with 3 descendants of its own.
  • 3 other devices also cite its predicate K920631.

How does its category compare?

All KZE devices

KZE Injector, Fluid, Non-Electrically Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KZE

1in 2012

2009: 42011: 22012: 1
2007high 4 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KZE

220in 2009

2009: 220 days median
2007high 220 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KZE

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KZE

1in 2025

2007: 542008: 52009: 82010: 92011: 72012: 62013: 42014: 102019: 12022: 12024: 12025: 1
2007high 54 (2007) · low 0 (2015)2025

MAUDE reports naming product code KZE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—054
20080—05
2009422008
20100—19
20112—07
20121—06
20130—04
20140—010
20150—00
20160—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—01
20230—00
20240—01
20250—01
20260—0—

What is it indicated for?

The Biojectorg 2000 is indicated for delivery of subcutaneous (SC) or intramuscular (IM) injections of vaccines and other injectable drugs. The Biojector® 2040 may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections. The Biojector* 2000 may also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed' medication.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K920631

3 other devices cite the same predicate.

  • K032976Biovalve Miniject Needle-Free Injection System, Model FG-01-001Biovalve Technologies, Inc. · 2004
  • K024018Avant Guardian 101Avant Medical Corporation · 2003
  • K960285Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug Delivery Systems 0.0058/0.0068(Inch Diameter…Medi-Ject Corp. · 1996

More from Bioject, Inc.

9 FDA decisions under this applicant name. See the company

  • K090003ZetajetBioject, Inc. · 20091 recall
  • K050734Cool.ClickBioject, Inc. · 2005
  • K010623Reconstitution Kit & Vial ConnectorBioject, Inc. · 2001
  • K003908SerojetBioject, Inc. · 2001
  • K994384ClickerBioject, Inc. · 2000

Recent decisions in KZE

The KZE category page

  • K121270Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc. · 2012
  • K111517Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis Injector Catalog 501-10, Stratis…Pharmajet, Inc. · 2011
  • K110456Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemPharmajet, Inc. · 2011
  • K090959Lectrajet Needle-Free Injection System, Model: M3 RAD'Antonio Consultants International, Inc. (Dci) · 2009
  • K090003ZetajetBioject, Inc. · 20091 recall

https://510kreport.com/device/K960373 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960373: Biojector 2000 Model 1B02000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960373

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026